Phase I Clinical Testing Antimalarial Drugs.
Abstract
The 52-week, safety and tolerance test administration of 500 mg mefloquine weekly continues. Four of the 5 groups (10 each) have compelted the drug administration interval. The only possible drug related adverse reaction observed was the occurrence of telogen effluvium (temporary scalp hair loss) in 2 subjects receiving drug. Three additional acute studies involving oral mefloquine administration were completed and reports submitted. These studies revealed gastrointestinal intolerance at the 1750 mg dose level of both (E-443 - B-512) formulations. Following administration of the newer formulation B-512, transient nausea and diarrhea occurred in some subjects receiving 1000 mg and all subjects receiving 1500 mg mefloquine. No other intolerance was observed at these dose levels. WR 184,806.H3PO4 studies were extended: serum and urine collections for pharmacokinetics following single oral dose administration of 250, 500, and 1000 mg doses have been completed. A new agent WR 180,409.H3PO4, a substituted pyridine methanol, underwent initial clinical testing using single rising dose levels.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1977
- Accession Number
- ADA046648
Entities
People
- Richard C. Reba